| Trial ID: | L7330 |
| Source ID: | NCT02146651
|
| Associated Drug: |
Biochaperone Insulin Lispro 0.2u/Kg
|
| Title: |
A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type 1
|
| Interventions: |
DRUG: BioChaperone insulin lispro 0.2U/Kg|DRUG: BioChaperone insulin lispro 0.1U/Kg|DRUG: BioChaperone insulin lispro 0.4U/Kg|DRUG: Humalog®
|
| Outcome Measures: |
Primary: Glucodynamic endpoint: Area Under the Curve GIR(0-last), Area under the Glucose Infusion Rate time curve from 0 hours until the end of the clamp, 12 hours|Glucodynamic endpoint: GIRMax, Maximum Glucose Infusion Rate, 12 hours|Pharmacokinetic endpoint: AUC Lisp(0-last), Area under the insulin lispro serum concentration - time curve over the clamp procedure., 12 hours|Pharmacokinetic endpoint: Cmax(Lisp), Maximum observed serum insulin lispro concentration, 12 hours | Secondary: Pharmacokinetics: Tmax(lisp), Time to maximum observed serum insulin lispro concentration, 12 hours|Glucodynamic: TGIRmax, Time to maximum Glucose Infusion Rate, 12 hours|Tonset of action, Time from t=0 until blood glucose concentration has decreased by 5mg.dL (0.3mmol.L) from baseline., 12 hours|Safety and Tolerability: adverse events, local tolerability, vital signs variations, ECG, laboratory safety parameters., 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Adocia
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
38
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-05
|
| Completion Date: |
2014-12
|
| Results First Posted: |
|
| Last Update Posted: |
2014-12-10
|
| Locations: |
Profil Institut für stoffwechselforschung GmbH, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02146651
|
